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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05453903




Registration number
NCT05453903
Ethics application status
Date submitted
8/07/2022
Date registered
12/07/2022

Titles & IDs
Public title
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
Scientific title
A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations
Secondary ID [1] 0 0
2021-003999-14
Secondary ID [2] 0 0
CR109124
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bleximenib
Treatment: Drugs - Venetoclax (VEN)
Treatment: Drugs - Azacitidine (AZA)
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin or Idarubicin

Experimental: Arm A: Relapsed/Refractory Setting - Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive bleximenib in combination with either venetoclax (VEN) (Cohort A1: bleximenib+VEN) or azacitidine (AZA) (Cohort A2: bleximenib +AZA) or VEN+AZA (Cohort A3: bleximenib+VEN+AZA) to select the recommended phase 2 dose (RP2D) of bleximenib in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive bleximenib in combination with AML directed therapies at the RP2D(s).

Experimental: Arm B: Newly Diagnosed Chemotherapy Ineligible Setting - Participants will receive bleximenib in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (\>=)75 years of age or \>= 18 years of age to less than (\<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.

Experimental: Arm C: Newly Diagnosed Chemotherapy Eligible Setting - Participants will receive combination of bleximenib with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants \>=18 to \<75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.


Treatment: Drugs: Bleximenib
Participants will receive bleximenib.

Treatment: Drugs: Venetoclax (VEN)
Participants will receive VEN.

Treatment: Drugs: Azacitidine (AZA)
Participants will receive AZA.

Treatment: Drugs: Cytarabine
Participants will receive cytarabine

Treatment: Drugs: Daunorubicin or Idarubicin
Participants will receive daunorubicin or idarubicin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 3 Years 3 months
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs) by Severity
Timepoint [2] 0 0
Up to 3 Years 3 months
Primary outcome [3] 0 0
Number of Participants with Dose-limiting Toxicity (DLT)
Timepoint [3] 0 0
End of Cycle 1 (28 days)
Secondary outcome [1] 0 0
Plasma Concentration of Bleximenib
Timepoint [1] 0 0
Up to 3 Years 3 months
Secondary outcome [2] 0 0
Number of Participants with Depletion of Leukemic Blasts
Timepoint [2] 0 0
Up to 3 Years 3 months
Secondary outcome [3] 0 0
Percentage of Participants who Achieve Complete Remission (CR)
Timepoint [3] 0 0
Up to 3 Years 3 months
Secondary outcome [4] 0 0
Percentage of Participants who Achieve Complete Remission with Partial Hematologic Recovery (CRh)
Timepoint [4] 0 0
Up to 3 Years 3 months
Secondary outcome [5] 0 0
Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
Timepoint [5] 0 0
Up to 3 Years 3 months
Secondary outcome [6] 0 0
Percentage of Participants who Achieved Overall Response
Timepoint [6] 0 0
Up to 3 Years 3 months

Eligibility
Key inclusion criteria
* Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed /refractory (Arm A only); c) harboring NPM1 / KMT2A alterations
* Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function
* ECOG performance status grade of 0, 1 or 2
* A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
* Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute promyelocytic leukemia according to WHO 2016 criteria
* Leukemic involvement of the central nervous system
* Recipient of solid organ transplant
* Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:(a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment ;(g)Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
* Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
* Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/03/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
France
State/province [7] 0 0
Marseille Cedex 9
Country [8] 0 0
France
State/province [8] 0 0
Toulouse Cedex 9
Country [9] 0 0
France
State/province [9] 0 0
Tours
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Germany
State/province [13] 0 0
Leipzig
Country [14] 0 0
Germany
State/province [14] 0 0
Ulm
Country [15] 0 0
Italy
State/province [15] 0 0
Bologna
Country [16] 0 0
Italy
State/province [16] 0 0
Meldola
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Rozzano
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Pamplona
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Manchester
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Oxfordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05453903